Bioequivalence and Bioavailability Forum

Hi kvgreddy06,

THX for reminding us!

❝ […] is going to be comes in effect from 02nd January 2014.

Where do you get this information from? It’s a draft and 20 comments have been submitted so far (although none are posted at regulations.gov yet).

Understandably the FDA wants to decrease its workload refusing failed and alternate designs without previous correspondence*.

line 640: FDA will refuse to receive an ANDA if only a failed study is submitted.
644–647: Submitting a non-recommended in vivo study without adequate justification will result in FDA refusing to receive an ANDA. We encourage applicants to consult the BE recommendations webpage for product-specific study information or to contact the Division of Bioequivalence via Control Correspondence for further guidance if needed.

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• In my experience mainly fishy attempts to “safe” a failed study by post-hoc changing the primary targets (PK metrics, metabolites, …).